Routine Versus Selective Midtrimester Ultrasound in a Poorly Resourced Setting: a Cluster Randomised Controlled Trial

It is debatable whether routine ultrasound scanning of pregnancies at about 20 weeks of pregnancy has substantive benefits for mothers and babies. Few studies have addressed this issue in poorly resourced settings. This trial will attempt to determine the benefits, if any, of a policy of routine ultrasound scanning of normal pregnancies versus a policy of no routine (only selective) scanning. This will be done by recruiting about 900 women in South Africa, and randomly allocating about half to routine scanning and half to selective scanning groups, and following up their pregnancies.

Study Overview

• Status: Completed
• Conditions: Fetal Congenital Abnormalities; Prolonged Pregnancy; Multiple Pregnancy
• Intervention / Treatment: Procedure: Routine midtrimester pregnany ultrasound scan

Detailed Description

Routine ultrasound scanning in the second trimester of pregnancy has few substantive benefits, according to the results of number of randomised trials, mostly performed in industrialised countries. While ultrasound did not seem to prevent fetal death, it was associated with improved detection of multiple pregnancies, improved detection of congenital abnormalities and reduced need for postterm labour induction. Only one trial, from Cape Town, has investigated the benefits of a policy of routine second trimester ultrasound scanning in an under-resourced setting.

This will be cluster randomised controlled trial, performed in the Krugersdorp area of South Africa, where most health service users are African, working class and dependent on government health facilities. About 900 low-risk pregnant women at less than 24 weeks gestation will be recruited, and randomised, in clusters, to either routine scanning or no scanning with recourse to selective scanning if clinically indicated.

Women will be followed up for maternal, fetal and neonatal outcome, and for indices of health service utilisation. Important outcome measures will be need for subsequent ultrasound,detection of multiple pregnancy, detection of congenital abnormalities, postterm pregnancy induction, still birth,and neonatal morbidity and mortality.

Data analysis will compare outcomes according to whether routine ultrasound scanning was or was not done, using standard statistical methods.

• Study Type: Interventional
• Enrollment: 900
• Phase: Phase 3

Contacts and Locations

Study Locations

• South Africa
  • Gauteng
    • Johannesburg, Gauteng, South Africa, 2000
      • University of Johannesburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Pregnancy, 24 weeks pregnant or less, willing to participate

Exclusion Criteria:

• High risk pregnancy condition, e.g. poor past obstetric history, hypertensive disease, previous caesarean section

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Detection of congenital abnormalities
Postterm pregnancy inductions

Secondary Outcome Measures

Outcome Measure
Detection of multiple pregnancies
Stillbirths
Neonatal morbidity
Neonatal mortality

Collaborators and Investigators

• Sponsor: University of Johannesburg
• Investigators: Study Chair: Eckhart J Buchmann, MBBCh, University of the Witwatersrand, Johannesburg

Study record dates

Study Major Dates

• Study Start: June 1, 2002
• Primary Completion: December 7, 2022
• Study Completion: May 1, 2004

Study Registration Dates

• First Submitted: September 12, 2005
• First Submitted That Met QC Criteria: September 12, 2005
• First Posted (Estimate): September 20, 2005

Study Record Updates

• Last Update Posted (Estimate): September 20, 2005
• Last Update Submitted That Met QC Criteria: September 12, 2005
• Last Verified: July 1, 2004

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Congenital Abnormalities; Pregnancy, Prolonged
• Other Study ID Numbers: BvanDyk USS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No